Manufacturing

BioTech Manufacturing is still Manufacturing. But with constraints from the FDA on Quality and Regulatory.

Pharmaceutical and Neutraceutical Processing and drug manufacturing can be broken down into a range of unit operations, such as blending, granulation, milling, coating, tablet pressing, filling, and others. 

BioTech Manufacturing adds words like “sterile,” “clinical,” “pristine,” and “highly controlled”, because it is “biologic” —namely the host cells used to grow the proteins that ultimately become a medicine.

Medical Devices combine the best of electronic, physical, software, and sometimes Pharmaceuticals to diagnose and treat our patients.

ALL are strictly guided by a “Quality” system that we tweak for our operations, but which must conform to standards set (and enforced) by regulatory agencies, like the FDA in the US. 

The place we go for our basic manufacturing knowledge, training, advocacy, etc on Our Island is: 

Ignite Long Island, our Manufacturing Consortium, understands how to achieve essential skills like Lean, Safety, Training, Inventory management, etc.

We help them add the skills that help our BioTech manufacturers develop, market, keep records, and ship!